SAMSUNG-BIOEPIS

Samsung Bioepis Announces RENFLEXIS™ (infliximab-abda) Now Available in the United States

Samsung Bioepis Co., Ltd. today announced the launch of RENFLEXIS™
(infliximab-abda), a biosimilar referencing Remicade®
(infliximab),
in the United States (US). RENFLEXIS™
was developed by
Samsung Bioepis, and is being commercialized in the US by Merck, which
is known as MSD outside of the US and Canada. RENFLEXIS™
was
approved by the US Food and Drug Administration (FDA) in April 2017.

“Since we were established five years ago, we have strived to bring
high-quality treatment options at a lower cost to US patients. RENFLEXIS
is our first step in meeting this important commitment,” said
Christopher Hansung Ko, President & CEO of Samsung Bioepis. “We firmly
believe biosimilars will play an instrumental role in making healthcare
more accessible to patients across the US, and we will continue our
relentless drive to advance one of the industry’s strongest pipelines.”

RENFLEXIS™
will be introduced in the US at a wholesale
acquisition cost of USD 753.39, a 35 percent discount to the current
wholesale acquisition cost of Remicade®
. Wholesale
acquisition costs do not include discounts that may be paid on the
products.

About RENFLEXIS™ (infliximab-abda) for
Injection, 100 mg

RENFLEXIS™
is a tumor necrosis factor (TNF) blocker approved
in the U.S. for the following indications.

Crohn’s Disease – RENFLEXIS™
is indicated for reducing signs
and symptoms and inducing and maintaining clinical remission in adult
patients with moderately to severely active Crohn’s disease who have had
an inadequate response to conventional therapy. RENFLEXIS™
is
indicated for reducing the number of draining enterocutaneous and
rectovaginal fistulas and maintaining fistula closure in adult patients
with fistulizing Crohn’s disease.

Pediatric Crohn’s Disease – RENFLEXIS™
is indicated for
reducing signs and symptoms and inducing and maintaining clinical
remission in pediatric patients 6 years of age and older with moderately
to severely active Crohn’s disease who have had an inadequate response
to conventional therapy.

Ulcerative Colitis – RENFLEXIS™
is indicated for reducing
signs and symptoms, inducing and maintaining clinical remission and
mucosal healing, and eliminating corticosteroid use in adult patients
with moderately to severely active ulcerative colitis who have had an
inadequate response to conventional therapy.

Rheumatoid Arthritis – RENFLEXIS™
, in combination with
methotrexate, is indicated for reducing signs and symptoms, inhibiting
the progression of structural damage, and improving physical function in
patients with moderately to severely active rheumatoid arthritis.

Psoriatic Arthritis – RENFLEXIS™
(infliximab-abda) is
indicated for reducing signs and symptoms of active arthritis,
inhibiting the progression of structural damage, and improving physical
function in patients with psoriatic arthritis.

Plaque Psoriasis – RENFLEXIS™
is indicated for the treatment
of adult patients with chronic severe (i.e., extensive and/or disabling)
plaque psoriasis who are candidates for systemic therapy and when other
systemic therapies are medically less appropriate. RENFLEXIS™
should only be administered to patients who will be closely monitored
and have regular follow-up visits with a physician.

Selected Safety Information about RENFLEXIS™
(infliximab-abda)

SERIOUS INFECTIONS

Patients treated with infliximab products are at increased risk for
developing serious infections that may lead to hospitalization or death.
Most patients who developed these infections were taking concomitant
immunosuppressants such as methotrexate or corticosteroids. Discontinue
RENFLEXIS™ if a patient develops a serious infection or sepsis.

Reported infections include:

Active tuberculosis (TB), including reactivation of latent TB.
Patients frequently presented with disseminated or extrapulmonary
disease. Patients should be tested for latent TB before RENFLEXIS™ use
and during therapy.1, 2 Treatment for latent
infection should be initiated prior to RENFLEXIS™ use.

Invasive fungal infections, including histoplasmosis,
coccidioidomycosis, candidiasis, aspergillosis, blastomycosis and
pneumocystosis. Patients may present with disseminated, rather than
localized, disease. Empiric anti-fungal therapy should be considered
in patients at risk for invasive fungal infections who develop severe
systemic illness.

Bacterial, viral, and other infections due to opportunistic
pathogens, including Legionella and Listeria.

The risks and benefits of treatment with RENFLEXIS™ should be
carefully considered prior to initiating therapy in patients with
chronic or recurrent infection. Closely monitor patients for the
development of signs and symptoms of infection during and after
treatment with RENFLEXIS™, including the possible development of TB in
patients who tested negative for latent TB infection prior to initiating
therapy, who are on treatment for latent TB, or who were previously
treated for TB infection.

Risk of infection may be higher in patients greater than 65 years of
age, pediatric patients, patients with co-morbid conditions and/or
patients taking concomitant immunosuppressant therapy. In clinical
trials, other serious infections observed in patients treated with
infliximab products included pneumonia, cellulitis, abscess, and skin
ulceration.

MALIGNANCIES

Lymphoma and other malignancies, some fatal, have been reported in
children and adolescent patients treated with TNF blockers, including
infliximab products.
Approximately half of these cases were
lymphomas, including Hodgkin's and non-Hodgkin's lymphoma. The other
cases represented a variety of malignancies, including rare malignancies
that are usually associated with immunosuppression and malignancies that
are not usually observed in children and adolescents. The malignancies
occurred after a median of 30 months after the first dose of therapy.
Most of the patients were receiving concomitant immunosuppressants.

Postmarketing cases of hepatosplenic T-cell lymphoma, a rare type of
T-cell lymphoma, have been reported in patients treated with TNF
blockers, including infliximab products. These cases have had a very
aggressive disease course and have been fatal. The majority of reported
cases have occurred in patients with Crohn’s disease or ulcerative
colitis and most were in adolescent and young adult males. Almost all of
these patients had received treatment with azathioprine or
6-mercaptopurine concomitantly with a TNF-blocker at or prior to
diagnosis. Carefully assess the risks and benefits of treatment with
RENFLEXIS™ (infliximab-abda), especially in these patient types.

In clinical trials of all TNF inhibitors, more cases of lymphoma were
observed compared with controls and the expected rate in the general
population. However, patients with Crohn’s disease, rheumatoid
arthritis, or plaque psoriasis may be at higher risk for developing
lymphoma. In clinical trials of some TNF inhibitors, including
infliximab products, more cases of other malignancies were observed
compared with controls. The rate of these malignancies among patients
treated with infliximab products was similar to that expected in the
general population, whereas the rate in control patients was lower than
expected. Cases of acute and chronic leukemia have been reported with
postmarketing TNF-blocker use. As the potential role of TNF inhibitors
in the development of malignancies is not known, caution should be
exercised when considering treatment of patients with a current or a
past history of malignancy or other risk factors such as chronic
obstructive pulmonary disease (COPD).

Melanoma and Merkel cell carcinoma have been reported in patients
treated with TNF-blocker therapy, including infliximab products.
Periodic skin examination is recommended for all patients, particularly
those with risk factors for skin cancer.

CONTRAINDICATIONS

RENFLEXIS™
(infliximab-abda) is contraindicated in patients
with moderate to severe (NYHA Class III/IV) congestive heart failure
(CHF) at doses greater than 5 mg/kg. Higher mortality rates at the 10
mg/kg dose and higher rates of cardiovascular events at the 5 mg/kg dose
have been observed in these patients. RENFLEXIS™
should be
used with caution and only after consideration of other treatment
options. Patients should be monitored closely. Discontinue RENFLEXIS™
if new or worsening CHF symptoms appear. RENFLEXIS™
should
not be (re)administered to patients who have experienced a severe
hypersensitivity reaction or to patients with hypersensitivity to murine
proteins or other components of the product.

HEPATITIS B REACTIVATION

TNF inhibitors, including infliximab products, have been associated with
reactivation of hepatitis B virus (HBV) in patients who are chronic
carriers. Some cases were fatal. Patients should be tested for HBV
infection before initiating RENFLEXIS™
. For patients who test
positive, consult a physician with expertise in the treatment of
hepatitis B. Exercise caution when prescribing RENFLEXIS™
for
patients identified as carriers of HBV and monitor closely for active
HBV infection during and following termination of therapy with RENFLEXIS™
.
Discontinue RENFLEXIS™
in patients who develop HBV
reactivation and initiate antiviral therapy with appropriate supportive
treatment. Exercise caution when considering resumption of RENFLEXIS™
and monitor patients closely.

HEPATOTOXICITY

Severe hepatic reactions, including acute liver failure, jaundice,
hepatitis, and cholestasis have been reported rarely in patients
receiving infliximab products postmarketing. Some cases were fatal or
required liver transplant. Aminotransferase elevations were not noted
prior to discovery of liver injury in many cases. Patients with symptoms
or signs of liver dysfunction should be evaluated for evidence of liver
injury. If jaundice and/or marked liver enzyme elevations (e.g., ≥5
times the upper limit of normal) develop, RENFLEXIS™
(infliximab-abda) should be discontinued, and a thorough investigation
of the abnormality should be undertaken.

HEMATOLOGIC EVENTS

Cases of leukopenia, neutropenia, thrombocytopenia, and pancytopenia
(some fatal) have been reported in patients using infliximab products.
The causal relationship to infliximab therapy remains unclear. Exercise
caution in patients who have ongoing or a history of significant
hematologic abnormalities. Advise patients to seek immediate medical
attention if they develop signs and symptoms of blood dyscrasias or
infection. Consider discontinuation of RENFLEXIS™
in patients
who develop significant hematologic abnormalities.

HYPERSENSITIVITY

Infliximab products have been associated with hypersensitivity reactions
that differ in their time of onset. Acute urticaria, dyspnea, and
hypotension have occurred in association with infusions of infliximab
products. Serious infusion reactions including anaphylaxis were
infrequent. Medications for the treatment of hypersensitivity reactions
should be available.

NEUROLOGIC EVENTS

TNF inhibitors, including infliximab products, have been associated in
rare cases with CNS manifestation of systemic vasculitis, seizure, and
new onset or exacerbation of CNS demyelinating disorders, including
multiple sclerosis and optic neuritis, and peripheral demyelinating
disorders, including Guillain-Barré syndrome. Exercise caution when
considering RENFLEXIS™
in patients with these disorders and
consider discontinuation if these disorders develop.

AUTOIMMUNITY

Treatment with infliximab products may result in the formation of
autoantibodies and, rarely, in development of a lupus-like syndrome.
Discontinue treatment if symptoms of a lupus-like syndrome develop.

Concomitant use of RENFLEXIS™
(infliximab-abda) with
anakinra, abatacept, tocilizumab or other biologics used to treat the
same conditions as RENFLEXIS™
is not recommended because of
the possibility of an increased risk of infection. Care should be taken
when switching from one biologic to another, since overlapping
biological activity may further increase the risk of infection.

LIVE VACCINES/THERAPEUTIC INFECTIOUS AGENTS

Live vaccines or therapeutic infectious agents should not be given with
RENFLEXIS™
due to the possibility of clinical infections,
including disseminated infections.

Bring pediatric patients up to date with all vaccinations prior to
initiating RENFLEXIS™
. At least a 6-month waiting period
following birth is recommended before the administration of any live
vaccine to infants exposed in utero
to infliximab products.

2. See latest Centers for Disease Control guidelines and recommendations
for tuberculosis testing in immunocompromised patients.

About Samsung Bioepis Co., Ltd.

Established in 2012, Samsung Bioepis is a biopharmaceutical company
committed to realizing healthcare that is accessible to everyone.
Through innovations in product development and a firm commitment to
quality, Samsung Bioepis aims to become the world's leading
biopharmaceutical company. Samsung Bioepis continues to advance a broad
pipeline of biosimilar candidates that includes six first-wave
candidates that cover the therapeutic areas of immunology, oncology and
diabetes. Samsung Bioepis is a joint venture between Samsung BioLogics
and Biogen. For more information, please visit: www.samsungbioepis.com
.